1 / 31

NABL ACCREDITATION

NABL ACCREDITATION . NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES (NABL). is an autonomous body registered under Societies Act in 1992 under the aegis of Department of Science & Technology, Government of India. NABL.

elgin
Télécharger la présentation

NABL ACCREDITATION

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. NABL ACCREDITATION

  2. NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES (NABL) is an autonomous body registered under Societies Act in1992 under the aegis of Department of Science & Technology, Government of India.

  3. NABL Grants accreditation in almost all areas of science, engineering and medical testing. The international standards followed are : ISO 15189:2007 (for Medical Testing) , ISO/IEC 17025:2005 (for Testing, calibration) & ISO 17043:2010 (for PT providers)

  4. The International Picture ILAC APLAC EA IAAC SADCA • NABL, India NABL ,as an accreditation body, operates its own system as per ISO/IEC 17011 . NABL is signatory to APLAC / ILAC Mutual Recognition Arrangements (MRA) since 2000 after its first evaluation by APLAC . Second & Thirdevaluation by APLAC in 2004 & 2008 respectively. Fourth evaluation Completed in Sep. 2012

  5. Scope of NABL Accreditation Testing Laboratories Biological Chemical Electrical Electronics Fluid-Flow Mechanical Non-Destructive Testing Optical and Photometry Radiological Thermal Forensic

  6. Scope of NABL Accreditation Calibration Laboratories Electro-Technical Mechanical Radiological Thermal Optical Fluid-Flow

  7. Scope of NABL Accreditation Medical Laboratories Clinical Biochemistry Clinical Pathology Genetics Cytopathology Hematology & Immuno-haematology Histopathology Microbiology& Serology Nuclear Medicine (only in-vitro tests)

  8. MEDICAL LABORATORY ACCREDITATION A very new concept Given by ISO (International Organisation of Standardization)

  9. Medical Laboratory Accreditation Compliance to ISO 15189 and getting it verified by third party Certificate of recognition (by NABL)

  10. Medical Laboratories-Particular requirements for quality and competence” Prepared by Technical Committee ISO/TC 212(medical laboratory professionals) Being used in most of the developed countries

  11. 1) True or reliable results(Accurate results) 2) Reproducible results( Precise results) 3) Timely release of the results(TAT)

  12. CERTIFICATION Vs ACCREDITATION Example ISO 9001:2005 Certification Certification does not make any statement about the technical competence of the laboratory.

  13. Accreditation-Example ISO 15189 Uses criteria specifically developed to determine technical competence of the laboratory. This is an independent evaluation of laboratory’s technical competence

  14. In Sept. 2009, a joint IAF-ILAC-ISO Communiqué was issued. It stated that “a medical laboratory’s fulfillment of the requirements of ISO 15189:2007 means the laboratory meets both the technical competence as well as management system requirements that are necessary for it to deliver technically valid test results.

  15. BENEFITS OF 15189 ACCREDITATION Stake holders- patients, insurance companies, referring clinicians Laboratories Other Benefits

  16. Benefits of Accreditation (contd) Accreditation benefits all stake holders. Benefits to the customers Customers can searchlaboratories: Customers can search and identify the laboratories accredited by NABL for their specific requirements from the NABL website or Directory of accredited laboratories.

  17. 2.Increased confidence in reports : The labs are required to participate in proficiency testing which is again demonstration of competence. So, there is increased confidence in the reports released by the laboratory. 3.The customers get services by credential staff. 6.Savings in terms of time and money as it reduces or eliminates the need of re-testing.

  18. Benefits of Accreditation (contd) Benefits for the laboratory: 1.Use of NABL symbol: The accredited laboratories can issue test reports bearing the accreditation body’s symbol or endorsement, as an indication of accreditation. 2.International Recognition: Lab accreditation is highly regarded both nationally and internationally as an indicator of technical competence 3.Satisfaction of the staff: The staff in an accredited laboratory is satisfied as it provides for continuous learning ,good working environment, leadership. .

  19. BENEFITS OF ACCREDITATION(CONTD) 4.Continuous improvement : Accreditation to a laboratory stimulates continuous improvement .It enables the laboratory in demonstrating commitment to quality test reports. 5.Systematic Control of lab work : Better control of laboratory operations and feedback to laboratories 6.Benchmark with best laboratories : It also provides opportunity to the laboratory to benchmark with the best

  20. 7.Rise in business : There is marked increase in the business of the labs as the accredited status can be seen by the clients on NABL website. Other Benefits: 1.It raises community confidence in the services provided by the laboratory. 2.Finally, Accreditation provides an objective system of empanelment by insurance and other third parties. 3.It encourages medical tourism.

  21. CGHS Empanelment In year 2009, mandatory NABL accreditation for CGHS empanelment gave a push which caused increased influx of application for accreditation. The impact could be seen in year 2010 & 2011 as increase in number of labs which were granted accreditation

  22. ACCREDITATION PROCESS Application for Accreditation (by Laboratory) Feedback to Laboratory and Necessary Corrective Action by Laboratory Acknowledgement & Scrutiny of Application (by NABL Secretariat) ) Adequacy of Quality Manual (by Lead Assessor) Pre-Assessment of Laboratory (by Lead Assessor) Final Assessment of Laboratory (by Assessment Team) Scrutiny of Assessment Report (by NABL Secretariat) Recommendations for Accreditation (by Accreditation Committee) Approval for Accreditation (( by Chairman NABL) Issue of Accreditation Certificate (by NABL Secretariat)

  23. Accreditation Certificate

  24. How scope is defined – Medical Laboratory (Biochemistry)(LAB - XYZ) Cont’d..

  25. SURVEILLANCE & RE-ASSESSMENT The Accreditation is valid for the period of 2 years. NABL conducts an annual Surveillance of the accredited laboratories. The laboratory must apply for renewal of accreditation at least six months before the expiry of validity of accreditation. A Re-assessment is similar to the final Assessment and is conducted before the expiry of Accreditation.

  26. Assessors Training Programs • NABL organizes its own Assessors’ training courses as per ISO/IEC 17025 and ISO 15189. • NABL has trained over 1000 assessors out of which 829 are presently empanelled. • NABL has organized Assessors’ training courses for Sri Lanka, Nepal, Bangladesh, Mauritius & Mongolia. • Assessors Conclave

  27. Customer Profile Private Medical Testing Laboratories : SRL Ranbaxy Limited, Mumbai Dr. Lal Path Labs Pvt., Ltd., New Delhi Max Labs 24X7, Max Super Speciality Hospital, New Delhi Apollo Gleneagles Hospitals, Kolkata Wockhardt Laboratory Services, Bangalore TATA Memorial Hospital – Diagnostic Services, Mumbai B. M. Birla Heart Research Centre, Kolkata Reliance Life Sciences Pvt. Ltd., Mumbai Manipal Acunova – Central Reference Laboratory, Bangalore Sir Ganga Ram Hospital, Clinical Laboratory Services, New Delhi Metropolis Health Services (India) private Limited, Mumbai

  28. Status of NABL Accreditation(as on 31st December 2012) • Testing Laboratories • Laboratories accredited : 1001 • Calibration Laboratories • Laboratories accredited : 396 • Medical Laboratories • Laboratories accredited : 392 Total Laboratories Accredited : 1789

  29. NABL WEBSITE NABL provides the information of Accredited laboratories in its web site www.nabl-india.org

  30. NABL ADDRESS NABL Secretariat (Contact Address) 3rd Fl., NISCAIR, 14 Satsang Vihar Marg, New Mehrauli Rd, New Delhi-110 067 Ph: 011 26529718/19/20/24649999 Fax : 011 26529716 Email: info@nabl-india.org Registered Office Department of Science & Technology Technology Bhavan New Mehrauli Road, New Delhi – 110 016

  31. THANKS

More Related